title: Safety and immunogenicity of a purified F protein respiratory syncytial virus (PFP-2) vaccine in seropositive children with bronchopulmonary dysplasia.
abstract: Respiratory syncytial virus (RSV) causes serious respiratory illness in preterm children with bronchopulmonary dysplasia. In a prospective randomized placebo-controlled trial, 21 children received one dose of PFP-2 (purified fusion [F] protein) vaccine or influenza vaccine (placebo). Children were followed for adverse reactions and RSV illness over two respiratory seasons. Sera were obtained for determination of IgG titers to RSV F protein and neutralizing antibody titers before and 1, 6, and 12 months after vaccination. Adverse reactions were few. Four-fold F protein rises occurred in 9 of 10 PFP-2 and 0 of 11 placebo recipients. Six PFP-2 recipients had low prevaccination neutralizing antibody titers (< 1:450); all had 4-fold rises. By 12 months, F protein and neutralizing antibody titers in all 21 children were similar. RSV illness occurred in 6 of 11 placebo versus 1 of 10 PFP-2 recipients (P = .06); 1 placebo child required hospitalization. PFP-2 vaccine appears safe and immunogenic and may protect children with bronchopulmonary dysplasia against serious RSV disease on reinfection.
authors.affiliation: Department of Pediatrics, University of Colorado, School of Medicine, Denver, USA.
authors.forename: J R
authors.initials: JR
authors.lastname: Groothuis
authors.forename: S J
authors.initials: SJ
authors.lastname: King
authors.forename: D A
authors.initials: DA
authors.lastname: Hogerman
authors.forename: P R
authors.initials: PR
authors.lastname: Paradiso
authors.forename: E A
authors.initials: EA
authors.lastname: Simoes
mesh_terms: D000914:Antibodies, Viral / Q000032:analysis / Q000276:immunology; D001997:Bronchopulmonary Dysplasia / Q000821:virology*; D002675:Child, Preschool; D004311:Double-Blind Method; D015707:HN Protein; D006760:Hospitalization; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis / Q000276:immunology; D007231:Infant, Newborn; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D009500:Neutralization Tests; D011446:Prospective Studies; D018357:Respiratory Syncytial Virus Infections / Q000276:immunology* / Q000517:prevention & control*; D012621:Seasons; D014759:Viral Envelope Proteins; D014764:Viral Proteins / Q000276:immunology*; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D015707:HN Protein; D007074:Immunoglobulin G; D007252:Influenza Vaccines; D014759:Viral Envelope Proteins; D014764:Viral Proteins; D014765:Viral Vaccines; C116204:attachment protein G